BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM

    MDR report key: 1210143 · Received October 20, 2008

    Report

    Report Number
    3005075853-2008-02424
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPROPER LOADING TECHNIQUE. EVALUATION SUMMARY: THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A PARTIALLY FIRED RELOAD IN THE DEVICE. THE RELOAD PAN WAS NOTED TO BE DISLODGED AND WITH DAMAGE ON THE PAN SURFACE. THE DAMAGE TO THE PAN IS CONSISTENT WITH AN IMPROPER LOADING TECHNIQUE. WHEN THE RELOAD IS PROPERLY LOADED IMPROPERLY, IT WILL BE EJECTED FORWARD AND SOME STAPLES WILL BE DEPLOYED (APPROXIMATELY HALF AWAY) AND MALFORMED BECAUSE OF INCORRECT ALIGNMENT. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE, A PIECE OF THE STAPLER BROKE OFF AND HAD TO BE RETRIEVED FROM THE PATIENT'S ABDOMEN. THERE WERE NO RESULTING STAPLE LINE COMPLICATIONS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC ARTICULATING LINEAR CUTTER (VASCULAR/THIN) - 35 MM GDW ETHICON ENDO-SURGERY, LLC. NA D4HF2F

    Patients

    Seq Age Sex Outcome Treatment
    1